Trial Outcomes & Findings for MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma (NCT NCT02575339)

NCT ID: NCT02575339

Last Updated: 2022-07-26

Results Overview

The primary objective for phase I of this study is to determine the maximum tolerated dose (MTD) of MLN0128. Maximum Tolerated Dose is defined as the dose level at which fewer than 33% of subjects experience a dose limiting toxicity (DLT).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: From start of treatment Day 1 (D1) until completion of two cycles of treatment (maximum 56 days)
• Results posted on: 2022-07-26

Participant Flow

Participant milestones

Measure	Phase I, Level 1: 15 mg of MLN0128 Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Study Treatment STARTED	7	4	0
Study Treatment COMPLETED	0	0	0
Study Treatment NOT COMPLETED	7	4	0
Follow up STARTED	7	4	0
Follow up COMPLETED	0	0	0
Follow up NOT COMPLETED	7	4	0

Reasons for withdrawal

Measure	Phase I, Level 1: 15 mg of MLN0128 Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Study Treatment Patient Withdrawal After Therapy Start	1	0	0
Study Treatment Disease Progression	5	2	0
Study Treatment Adverse Event	1	2	0
Follow up Death	6	2	0
Follow up Study Terminated	0	2	0
Follow up Death due to progressive disease after coming off treatment early	1	0	0

Baseline Characteristics

MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level	Total n=11 Participants Total of all reporting groups
Age, Continuous	65.1 year STANDARD_DEVIATION 12.6 • n=5 Participants	64.3 year STANDARD_DEVIATION 3.0 • n=7 Participants	—	64.8 year STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	—	3 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	—	8 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	7 Participants n=5 Participants	3 Participants n=7 Participants	—	10 Participants n=4 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	—	1 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic	6 Participants n=5 Participants	3 Participants n=7 Participants	—	9 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	—	1 Participants n=4 Participants
ECOG PS, n(%) 0	4 Participants n=5 Participants	0 Participants n=7 Participants	—	4 Participants n=4 Participants
ECOG PS, n(%) 1	3 Participants n=5 Participants	4 Participants n=7 Participants	—	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: From start of treatment Day 1 (D1) until completion of two cycles of treatment (maximum 56 days)

Population: Data for this primary objective was neither collected nor analyzed due to the early termination of the study by the funder.

The primary objective for phase I of this study is to determine the maximum tolerated dose (MTD) of MLN0128.

Maximum Tolerated Dose is defined as the dose level at which fewer than 33% of subjects experience a dose limiting toxicity (DLT).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 7 months (estimated).

Population: Data for this primary objective was neither collected nor analyzed due to the early termination of the study by the funder.

The primary endpoint of Phase II of the study is to evaluate the time to progression, which is defined as the time from randomization until tumor progression as defined by RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until 30 days after the last treatment, assessed for estimated 7 cycles (est. 196 days)

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Toxicity assessed using Common Terminology Criteria for Adverse Events v4.0 (CTCAE) criteria

Outcome measures

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Phase I: Characterize Adverse Effects (AE) Patient had at least 1 Grade 3 or greater AE	5 Participants	3 Participants	—
Phase I: Characterize Adverse Effects (AE) Patient had at least 1 Grade 3 or greater treatment related AE	2 Participants	2 Participants	—
Phase I: Characterize Adverse Effects (AE) Patient having serious adverse event	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From date of registration until death from any cause, up to a maximum of 27 months

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Overall Survival of subjects receiving MLN0128 is defined by the time from randomization to date of death from any cause.Here median overall survival in months has been reported for subjects per dose level with 95% confidence interval.

Outcome measures

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Phase I: Overall Survival (OS) Rate	5.78 months Interval 2.74 to 15.68	10.58 months Interval 6.48 to 12.78	—

SECONDARY outcome

Timeframe: From date of registration until death from any cause, up to a maximum of 24 months

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Overall Survival of subjects randomized to both MLN0128 and sorafenib arms is defined by the time from randomization to date of death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 6 months (estimated).

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Time to progression (TTP) of subjects receiving MLN0128 assessed using RECIST v1.1 criteria is defined as the time from randomization until tumor progression as defined by RECIST v1.1. Here median Time to Progression in months has been reported for subjects per dose level with 95% confidence interval.

Outcome measures

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Phase I: Time to Progression (TTP)	1.77 months Interval 0.57 to 1.83	2.83 months Interval 1.42 to 5.52	—

SECONDARY outcome

Timeframe: From date of randomization to tumor progression or death from any cause, up to a maximum of 6 months

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Progression free survival (PFS) of subjects receiving MLN0128 assessed using RECIST v1.1 criteria is defined by time from randomization to tumor progression or death from any cause. Here median Progression-free survival in months has been reported for subjects per dose level with 95% confidence interval.

Outcome measures

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Phase I: Progression-free Survival (PFS)	1.81 months Interval 1.27 to 3.99	2.83 months Interval 1.42 to 5.52	—

SECONDARY outcome

Timeframe: From date of randomization to tumor progression or death from any cause, up to a maximum of 24 months

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Progression Free Survival of subjects randomized to both MLN0128 and sorafenib arms assessed using RECIST v1.1 criteria, is defined as time from randomization to tumor progression or death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Objective Response Rate is assessed at 16 weeks and 24 weeks from start of treatment cycle until Progressive disease is documented.

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Objective Response Rate (ORR) of subjects receiving MLN0128 defined as complete response (CR)+partial response (PR), as defined by RECIST v1.1.

Outcome measures

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Phase I: Objective Response Rate (ORR)	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Disease Control Rate is assessed at 16 weeks and 24 weeks from start of treatment cycle until Progressive disease is documented.

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Disease Control Rate (DCR) of subjects receiving MLN0128 as a sum of stable disease (SD for 8 weeks or longer), partial response (PR), and complete response (CR), as defined by RECIST v1.1.

Outcome measures

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 Participants Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 Participants Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Phase I: Disease Control Rate (DCR)	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: From date of first dose until 30 days after the last treatment, assessed for estimated 7 cycles (est. 196 days)

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Toxicity for subjects randomized to both MLN0128 and sorafenib arms, assessed using CTCAE v4 criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Radiographic Response Rate is assessed at 16 weeks and 24 weeks from start of treatment cycle until Progressive disease is documented.

Population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual.

Radiographic Response Rate for subjects randomized to both MLN0128 and sorafenib arms, determined utilizing objective response rate (ORR) and disease control rate (DCR) at 16 and 24 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Phase I, Level 1: 15 mg of MLN0128

Serious events: 1 serious events

Other events: 7 other events

Deaths: 7 deaths

Phase I, Level 2: 20mg of MLN0128

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Phase I, Level 3: 30mg of MLN0128

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 participants at risk Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 participants at risk Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Gastrointestinal disorders GASTRIC HEMORRHAGE	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.

Other adverse events

Measure	Phase I, Level 1: 15 mg of MLN0128 n=7 participants at risk Subjects at Phase I, level 1 will receive 15mg of MLN0128 orally once weekly per dose level	Phase I, Level 2: 20mg of MLN0128 n=4 participants at risk Subjects at Phase I, level 2 will receive 20mg of MLN0128 orally once weekly per dose level	Phase I, Level 3: 30mg of MLN0128 Subjects at Phase I, level 3 will receive 30mg of MLN0128 orally once weekly per dose level
Gastrointestinal disorders ABDOMINAL PAIN	42.9% 3/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Renal and urinary disorders ACUTE KIDNEY INJURY	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations ALANINE AMINOTRANSFERASE INCREASED	28.6% 2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations ALKALINE PHOSPHATASE INCREASED	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders ANAL FISTULA	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Blood and lymphatic system disorders ANEMIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders ANOREXIA	57.1% 4/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Psychiatric disorders ANXIETY	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Musculoskeletal and connective tissue disorders ARTHRITIS	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	75.0% 3/4 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders ASCITES	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	42.9% 3/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	75.0% 3/4 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Cardiac disorders ATRIAL FIBRILLATION	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Musculoskeletal and connective tissue disorders BACK PAIN	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders BLOATING	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations BLOOD BILIRUBIN INCREASED	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Injury, poisoning and procedural complications BRUISING	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders CHILLS	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations CHOLESTEROL HIGH	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Psychiatric disorders CONFUSION	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders CONSTIPATION	57.1% 4/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	75.0% 3/4 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Respiratory, thoracic and mediastinal disorders COUGH	14.3% 1/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations CREATININE INCREASED	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Psychiatric disorders DEPRESSION	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders DIARRHEA	57.1% 4/7 • Number of events 6 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	75.0% 3/4 • Number of events 5 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders DRY MOUTH	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Nervous system disorders DIZZINESS	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Nervous system disorders DYSGEUSIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders DYSPHAGIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Ear and labyrinth disorders EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders EDEMA LIMBS	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Eye disorders EYE DISORDERS - OTHER, SPECIFY	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders FATIGUE	100.0% 7/7 • Number of events 9 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	100.0% 4/4 • Number of events 9 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders FLATULENCE	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders FEVER	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders FLU LIKE SYMPTOMS	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	14.3% 1/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Reproductive system and breast disorders GYNECOMASTIA	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Nervous system disorders HEADACHE	28.6% 2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Ear and labyrinth disorders HEARING IMPAIRED	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Infections and infestations HEPATITIS VIRAL	57.1% 4/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders HYPERCALCEMIA	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders HYPERGLYCEMIA	42.9% 3/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	100.0% 4/4 • Number of events 8 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Vascular disorders HYPERTENSION	71.4% 5/7 • Number of events 7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	75.0% 3/4 • Number of events 7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Endocrine disorders HYPERTHYROIDISM	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders HYPERURICEMIA	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders HYPOALBUMINEMIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders HYPONATREMIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders HYPOKALEMIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Vascular disorders HYPOTENSION	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Immune system disorders IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Psychiatric disorders INSOMNIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations LYMPHOCYTE COUNT DECREASED	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders MUCOSITIS ORAL	28.6% 2/7 • Number of events 5 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	75.0% 3/4 • Number of events 7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Musculoskeletal and connective tissue disorders MYALGIA	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders NAUSEA	71.4% 5/7 • Number of events 5 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	100.0% 4/4 • Number of events 8 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	50.0% 2/4 • Number of events 5 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders NON-CARDIAC CHEST PAIN	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Metabolism and nutrition disorders OBESITY	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders ORAL PAIN	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
General disorders PAIN	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	28.6% 2/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Cardiac disorders PALPITATIONS	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations PLATELET COUNT DECREASED	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Hepatobiliary disorders PORTAL VEIN THROMBOSIS	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Respiratory, thoracic and mediastinal disorders POSTNASAL DRIP	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Reproductive system and breast disorders REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Respiratory, thoracic and mediastinal disorders SINUS DISORDER	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Nervous system disorders SPASTICITY	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Ear and labyrinth disorders TINNITUS	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Infections and infestations TOOTH INFECTION	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Renal and urinary disorders URINARY RETENTION	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Vascular disorders VASCULAR DISORDERS - OTHER, SPECIFY	14.3% 1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Gastrointestinal disorders VOMITING	42.9% 3/7 • Number of events 5 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	0.00% 0/4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations WEIGHT LOSS	28.6% 2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
Investigations WHITE BLOOD CELL DECREASED	0.00% 0/7 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	25.0% 1/4 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.	— 0/0 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s). Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: amajumdar@hoosiercancer.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place